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Recruiting NCT07064798

Cryocompression for CIPN

No phase Interventional Chemotherapy-induced Peripheral Neuropathy Taxane-Induced Peripheral Neuropathy CIPN - Chemotherapy-Induced Peripheral Neuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Paxman Limb Cryocompression System.
Who it may be relevant to
Registry conditions: Chemotherapy-induced Peripheral Neuropathy, Taxane-Induced Peripheral Neuropathy, CIPN - Chemotherapy-Induced Peripheral Neuropathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating the Use of Limb Cryocompression to Reduce Taxane-induced Peripheral Neuropathy

Overview

This study aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. The name of the device used in this research study is: -Paxman Limb Cryocompression System (PLCS)

Detailed description

This randomized controlled trial aims to evaluate the effectiveness, tolerability, and safety of using cooling therapy and pressure (cryocompression) to reduce peripheral neuropathy, a condition affecting the nerves supplying the arms and legs (limbs) resulting in possible numbness, pain, and/or loss of motor function, that may occur as a result of taxane-based chemotherapy. There is evidence that cooling therapy may be effective for preventing peripheral neuropathy caused by taxane-based chemotherapy.

The U.S. Food and Drug Administration (FDA) has not approved the PAXMAN Limb Cryocompression System as a treatment to reduce peripheral neuropathy.

Participants will be randomized into 1 of 2 groups: Arm A: Cryocompression + Standard of Care Taxane-Based Chemotherapy versus Arm B: Standard of Care Taxane-Based Chemotherapy. Participants will be randomized in a 2:1 manner, meaning a participant is 2 times the chance (approximately 67%) of being in Arm A than in Arm B (approximately 33%). Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-clinic visits, and questionnaires.

It is expected that about 50 people will take part in this research study.

Paxman Coolers, Inc. is providing the Paxman Limb Cryocompression Systems for this study.

Interventions

  • Device Paxman Limb Cryocompression System
    An investigational device designed to provide controlled cooling and compression to participant limbs during chemotherapy administration. The device is comprised of a control unit, connecting hose, and two limb wraps. The customizable limb wraps delivers continuous-flow cooling-and-compression to participant extremities

Primary outcome measures

  • Change in Patient-Reported CIPN Symptoms Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy module at End of Treatment [Time frame: Assessed 1-4 weeks after the final taxane infusion (end of treatment).]
  • Duration of Cryocompression Tolerated During Neurotoxic Chemotherapy [Time frame: Up to 12 weeks]
  • Incidence of Core Temperature Decrease >1°F and Skin Intolerance Symptoms Associated with Cryocompression [Time frame: Throughout each chemotherapy infusion visit when cryocompression is applied. Up to 12 weeks]

Eligibility criteria

Inclusion criteria

  • Adults > 18 years of age
  • Gynecologic or breast malignancy
  • Starting 1st cycle of treatment with chemotherapy regimens:
  • Weekly paclitaxel x 12 or weekly paclitaxel/carboplatin x 12, Q2 weeks paclitaxel X4 (preceded by doxorubicin/cyclophosphamide). (Breast Oncology)
  • Q3 weeks paclitaxel/carboplatin X 6-8 (GYN)
  • Receiving treatment on the main campus of DFCI (these patients are currently seen on Yawkey 9 and 10 and at Chestnut Hill)
  • Able to complete questionnaires in English or Spanish

Exclusion criteria

  • Previous exposure to neurotoxic chemotherapy
  • Pre-existing neuropathy
  • History of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, peripheral arterial ischemia, or sickle cell disease
  • Undergoing desensitization
  • Lymphedema in the limb where the device would be applied
  • Open skin wounds or ulcers of the limbs where the device would be applied

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT07064798 · 25-144

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗